Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System

NCT04861805 | Recruiting DMC

• 1 other identifier: CTP-VIE-001
• Study Type: interventional
• Target: 267
• Locations: 8 countries
• Sites: 31

Brief Summary

This is a prospective, single arm, multicenter study in an cohort of up to 267 patients (up to 100 Roll-ins and 167 patients implanted per protocol) symptomatic patients with severe aortic stenosis who will be followed up for up to 5 years.

Conditions

Symptomatic Aortic Stenosis

Keywords

heart disease; aortic valve; SSAS; symptomatic severe aortic stenosis; heart valve

Outcome Measures

Primary Outcomes (1)

• All Cause Mortality (30 days)

  All-cause mortality at 30 days from the index procedure.

  up to 30 days

Secondary Outcomes (14)

• All-cause, cardiovascular and non-cardiovascular mortality

  up to 5 years

• Periprocedural death

  72 hours

• Incidence of TAVI-related complications

  periprocedural and during index hospitalization

• Cerebrovascular event

  Up to 5 years

• Life-threatening bleeding

  Up to 1 year

Study Arms (1)

Vienna Aortic Valve

OTHER

transcatheter aortic valve implantation (TAVI)

Device: Vienna Aortic Valve SE System

Interventions

Vienna Aortic Valve SE System DEVICE

Vienna Aortic Valve SE system for TAVI.

Vienna Aortic Valve

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Male or Female
• Age ≥ 65 years at time of consent
• Women of non-childbearing potential
• Severe degenerative calcific native aortic valve stenosis with the following criteria assessed either by resting or dobutamine stress TTE:
• Aortic valve area (AVA) \< 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 and
• Jet velocity \> 4.0 m/s or mean gradient \> 40 mmHg
• Symptomatic aortic stenosis (AS), defined as a history of at least one of the following:
• Dyspnea that qualifies at NYHA class II or greater
• Angina pectoris
• Cardiac syncope
• Subject is considered at intermediate or high risk for surgical valve replacement based on at least one of the following:
• EuroSCORE II ≥ 4% along with assessment of frailty, major organ system dysfunction, and procedure-specific impediments, in accordance with scientific guidelines
• Agreement by the Heart Team that subject is at moderate to high operative risk of serious morbidity or mortality with surgical valve replacement.
• The local Heart Team deems the patient to be eligible for transfemoral TAVI.
• Perimeter-based aortic annulus diameter between ≥ 18 and ≤ 29 mm measured by computed tomography (CT) analyzed by a core lab.

You may not qualify if:

• Cardiovascular System:
• Patient has a congenital unicuspid or bicuspid aortic valve or non-calcified valves.
• Evidence of an acute myocardial infarction (MI) ≤ 30 days prior to screening or IMD implantation (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation).
• Patient has had a cerebrovascular stroke or TIA within the past 90 days implantation prior to screening or valve implantation.
• Patient has a hypertrophic obstructive cardiomyopathy.
• History of any therapeutic invasive cardiac procedure (including balloon aortic valvuloplasty) within 30 days prior to screening or IMD implantation (except for pacemaker implantation which is allowed).
• Untreated clinically significant coronary artery disease requiring revascularization at the screening visit.
• Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
• Patient with cardiogenic shock manifested by low cardiac output and hemodynamic instability and vasopressor dependence, or mechanical hemodynamic support
• Patients with clinically significant conduction abnormalities (clinically significant sinus bradycardia, sinus block or pauses, clinically significant atrioventricular (AV)-block \>I) at screening and at time of IMD implantation.
• Patient has severe peripheral vascular disease:
• including aortic aneurysm defined as maximal luminal diameter \> 5 cm or with documented presence of thrombus, marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta or thick \[\> 5 mm\], protruding or ulcerated atheroma in the aortic arch) or
• symptomatic carotid or vertebral disease or successful treatment of carotid stenosis within 30 days prior to screening or IMD implantation.
• Patient with iliofemoral vessel characteristics that would preclude safe passage of the introducer (both sides), as analyzed by a core lab:
• severe calcification,

Sponsors & Collaborators

• P+F Products + Features GmbH: lead
• Meditrial USA Inc.: collaborator

Study Sites (31)

Hospital Privado Sur (FUMEBA)

Bahía Blanca, B8000, Argentina

NOT YET RECRUITING

Fundación Favaloro

Buenos Aires, C1093, Argentina

NOT YET RECRUITING

Hospital Italiano De Buenos Aires

Buenos Aires, C1199ABB, Argentina

NOT YET RECRUITING

Instituto Nacional de Cardiologia

Rio de Janeiro, Rio de Janeiro, 22240-006, Brazil

NOT YET RECRUITING

Escola Paulista de Medicina da UNIFESP

São Paulo, São Paulo, 04023-062, Brazil

NOT YET RECRUITING

Instituto Estadual De Cardiologia Aloysio De Castro

Rio de Janeiro, 22261-010, Brazil

RECRUITING

Instituto Dante Pazzanese De Cardiologia

São Paulo, 04012-909, Brazil

RECRUITING

Instituto Do Coração (InCor) De São Paulo

São Paulo, 05403-900, Brazil

RECRUITING

Hospital Del Torax De Santiago

Santiago, 7500691, Chile

RECRUITING

Hospital Clínico San Borja Arriarán

Santiago, 8360160, Chile

RECRUITING

Hospital Las Higueras - Talcahuano

Talcahuano, 4270940, Chile

RECRUITING

Narayana Health, Multispeciality Hospital

Bangalore, 560099, India

NOT YET RECRUITING

Medanta - The Medicity Multi-Speciality Hospital

Gūrgaon, 122001, India

NOT YET RECRUITING

RHL- Rajasthan Hospital

Jaipur, 302018, India

NOT YET RECRUITING

LISIE Hospital

Kochi, 682017, India

NOT YET RECRUITING

Christian Medical College Hospital

Vellore, 632 004, India

NOT YET RECRUITING

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, Kaunas County, 50161, Lithuania

RECRUITING

Hospital Santa Marta

Lisbon, Lisbon District, 1169-024, Portugal

RECRUITING

Hospital Santa Maria

Lisbon, Lisbon District, 1649-028, Portugal

RECRUITING

Hospital de Santa Cruz

Carnaxide, 2790-134, Portugal

RECRUITING

Unidade Local de Saúde de Gaia e Espinho

Vila Nova de Gaia, 4434-502, Portugal

RECRUITING

Hospital do Espírito Santo de Évora

Evora, Évora District, 7000-811, Portugal

NOT YET RECRUITING

Hospital Clinic De Barcelona

Barcelona, Barcelona, 08036, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

RECRUITING

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

RECRUITING

University Clinical Hospital of Valladolid

Valladolid, Valladolid, 47003, Spain

RECRUITING

Hospital Puerta De Hierro

Majadahonda, 28222, Spain

RECRUITING

Hospital Virgen De La Victoria

Málaga, 29010, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

NOT YET RECRUITING

İ.A.Ü. VM Medical Park Florya Hospital

Istanbul, Istanbul, 34295, Turkey (Türkiye)

NOT YET RECRUITING

Related Publications (3)

• Briedis K, Rumbinaite E, Aldujeli A, Briede K, Jurenas M, Jakuska P, Jankauskas A, Ceponiene I, Lenkutis T, Plisiene J, Benetis R, Zaliunas R. One-year initial efficacy and safety outcomes of the premounted dry-pericardium Vienna self-expandable transcatheter aortic valve system: A first-in-human VIVA feasibility study. Catheter Cardiovasc Interv. 2024 Jun;103(7):1111-1124. doi: 10.1002/ccd.31039. Epub 2024 Apr 9.

  PMID: 38591535 DERIVED

• Briedis K, Aldujeli A, Zaliunas R, Benetis R. Early Safety and Performance of the Premounted Dry-Pericardium Vienna Self-Expandable Transcatheter Aortic Valve System: 30-Day Outcomes of the First-in-Human VIVA Feasibility Study. Am J Cardiol. 2023 Oct 1;204:302-311. doi: 10.1016/j.amjcard.2023.07.109. Epub 2023 Aug 9.

  PMID: 37567022 DERIVED

• Briedis K, Mizariene V, Rumbinaite E, Jurenas M, Aldujeli A, Briede K, Jakuska P, Jankauskas A, Ceponiene I, Lenkutis T, Zaliunas R, Benetis R. Safety and performance of the Vienna self-expandable transcatheter aortic valve system: 6-month results of the VIVA first-in-human feasibility study. Front Cardiovasc Med. 2023 Jul 13;10:1199047. doi: 10.3389/fcvm.2023.1199047. eCollection 2023.

  PMID: 37522086 DERIVED

Related Links

• Products \& Features, manufacturer of VIVA Transcatheter Aortic Valve System
• Meditrial Clinical Research Organization

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Alexandre Abizaid, MD

  Instituto do Coração (InCor) de São Paulo

  PRINCIPAL INVESTIGATOR

• Carla Agatiello, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

• Alejandro Alvarez Iorio, MD

  Hospital Privado Sur (FUMEBA)

  PRINCIPAL INVESTIGATOR

• Ignacio J Amat-Santos, MD

  University Clinical Hospital of Valladolid

  PRINCIPAL INVESTIGATOR

• Rimantas Benetis, MD

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Pedro Braga, MD

  Unidade Local de Saúde de Gaia e Espinho

  PRINCIPAL INVESTIGATOR

• Juan Horacio A Briales, MD

  Hospital Virgen de la Victoria

  PRINCIPAL INVESTIGATOR

• João Brito, MD

  Hospital de Santa Cruz

  PRINCIPAL INVESTIGATOR

• Duarte Cacela, MD

  Hospital Santa Marta

  PRINCIPAL INVESTIGATOR

• Adriano M Caixeta, MD

  Escola Paulista de Medicina da UNIFESP

  PRINCIPAL INVESTIGATOR

• Praveen Chandra, MD

  Medanta - The Medicity Hospital

  PRINCIPAL INVESTIGATOR

• Christian Dauvergne, MD

  Hospital del Tórax de Santiago

  PRINCIPAL INVESTIGATOR

• Pedro C Ferreira, MD

  Hospital Santa Maria

  PRINCIPAL INVESTIGATOR

• John Jose E, MD

  Christian Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Rony Mathew Kadavil, MD

  Lisie Hospital

  PRINCIPAL INVESTIGATOR

• Gabriel Maluenda, MD

  Hospital Clínico San Borja Arriarán

  PRINCIPAL INVESTIGATOR

• Cesar R Medeiros, MD

  Instituto Nacional de Cardiologia

  PRINCIPAL INVESTIGATOR

• Oscar Mendiz, MD

  Fundación Favaloro

  PRINCIPAL INVESTIGATOR

• Sanjay Mehrotra, MD

  Narayana Health Hospital

  PRINCIPAL INVESTIGATOR

• Marcio J Montenegro Da Costa, MD

  Instituto Estadual de Cardiologia Aloysio de Castro

  PRINCIPAL INVESTIGATOR

• Cesar Morís de La Tassa, MD

  Hospital Universitario Central de Asturias

  PRINCIPAL INVESTIGATOR

• Luis Nombela, MD

  Hospital San Carlos, Madrid

  PRINCIPAL INVESTIGATOR

• Juan Oteo, MD

  Hospital Puerta De Hierro

  PRINCIPAL INVESTIGATOR

• Lino MD Patrício, MD

  Hospital do Espírito Santo de Évora

  PRINCIPAL INVESTIGATOR

• Osvaldo Perez, MD

  Hospital Las Higueras - Talcahuano

  PRINCIPAL INVESTIGATOR

• Ravinder Singh Rao, MD

  RHL - Rajasthan Hospital

  PRINCIPAL INVESTIGATOR

• Ángel S Recalde, MD

  Hospital Universitario Ramón y Cajal

  PRINCIPAL INVESTIGATOR

• Ander Regueiro, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• Lluis A Serra, MD

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

• Dimytri Siqueira, MD

  Instituto Dante Pazzanese de Cardiologia

  PRINCIPAL INVESTIGATOR

• Hakan Ucar, MD

  İ.A.Ü. VM Medical Park Florya Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharina Kiss, Dr

CONTACT

+4369913289414; kkiss@productsandfeatures.com

Monica Tocchi, MD, PhD

CONTACT

9176841700; m.tocchi@meditrial.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, single arm, multicenter pivotal study in an expanding cohort of symptomatic patients with severe aortic stenosis (following the initial FIH feasibility study).

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 27, 2021
• Study Start: July 3, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2030
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1); ES (8); IN (5); AR (3); CL (3); PT (5); LI (1); BR (5)